Pathway CH S&E Registry
- Conditions
- Cluster Headache
- Registration Number
- NCT02440776
- Lead Sponsor
- Autonomic Technologies, Inc.
- Brief Summary
Monitor the safety and performance of the Pulsante Microstimulator System.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- Patient meets CE marked labeling for cluster headache.
- Patient has the ability to read, comprehend and reliably record information as required by the Protocol.
- Patient is able to provide written informed consent prior to participation in the study.
- Patient has other significant pain problem that might confound the study assessments in the opinion of the Investigator.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Characterization of all device/procedure related Adverse Events Through five years post implant Outcome will be assessed at Implant, 3, 6, 9, 12, 18, 24, 36, 48 and 60 months post implant.
- Secondary Outcome Measures
Name Time Method Acute response to therapy Through five years post implant Outcome will be assessed at 3, 6, 9, 12, 18, 24, 36, 48 and 60 months post implant.
Trial Locations
- Locations (9)
Klinik für Schmerztherapie, Rotes Kreuz Krankenhaus, Hansteinstr. 29
🇩🇪Kassel, Germany
Neurologie + Kopfschmerzzentrum Münchner Freiheit
🇩🇪Munich, Germany
University Hospital Zurich, Klinik f. Neurologie, Frauenklinikstr. 26
🇨🇭Zurich, Switzerland
Universitätsklinikum Freiburg
🇩🇪Freiburg, Germany
Heinrich-Heine-University
🇩🇪Düsseldorf, Germany
Rigshospitalet Neurocenter
🇩🇰Glostrup, Denmark
The Walton Center
🇬🇧Liverpool, United Kingdom
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Klinik und Poliklinik für Neurologie
🇩🇪Dresden, Germany
Neurologiska Kliniken-Karolinska UniversitetssjukhusetSolna
🇸🇪Stockholm, Sweden